낭포성 섬유증이 있는 청소년 및 청년의 신체 활동을 촉진하기 위한 맞춤형 모바일 건강 플랫폼 (NUDGE)
The goal of this clinical trial is to help adolescents and young adults between the ages of 13-25 with Cystic Fibrosis (CF), medically stable, able to speak and read English, and are not experiencing a CF - related exacerbation, who are already active to remain, or gradually encourage them to increase their levels of physical activity
Participants will be asked to utilize a smartphone program, called NUDGE that we have developed. NUDGE is a chatbot with evidence-based features known to help teens make progress toward health goal:
- Set and review goals
- Self-monitor progress
- Provide feedback on goal attainment
- Revise future goals
연구 개요
상세 설명
The goal of this study is to conduct a 6-month delayed treatment pilot Trial with adolescents and young adults (AYA) ages 13-25 with Cystic Fibrosis (CF) or a CF related disorder) to establish feasibility and obtain data necessary to inform a Phase III efficacy trial. AYAs 18 years-old and caregivers of AYAs 13-17 years-old will complete the informed consent process. AYAs 13-17 years-old will be asked to assent to participate in the study. After completion of the baseline study measures and return of actigraphy monitors, staff will notify AYAs of their randomized assignment. AYAs receiving NUDGE will then begin receiving intervention content for 6 months. AYAs randomized to control will receive NUDGE at the conclusion of the Month 3 study visit. Study visits will occur at Months 0, 3, and 6 with staff masked to treatment assignment.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
Florida
-
Jacksonville, Florida, 미국, 32207
- Nemours Childrens Health
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- 13-25 years old
- Has a verified CF diagnosis or CF-related disorder
- Medically stable (i.e., FEV1>30%, not experiencing a CF-related exacerbation)
- Speaks and reads English
Exclusion Criteria:
- Have a comorbidity limiting PA participation (e.g., neurological condition)
- Have a significant cognitive impairment that interferes with study completion
- Have any oxygen, CPAP or BiPAP requirement
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
활성 비교기: 교육
|
Individuals will receive educational materials about how to increase physical activity |
|
실험적: 슬쩍 찌르다
|
Individuals in this condition will receive intervention content to promote physical activity. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Recruitment
기간: Baseline
|
Recruitment: Our recruitment goal is 30 AYAs with CF. |
Baseline
|
|
Retention
기간: 3-month
|
Retention: Our criterion for success is no more than 20% attrition. |
3-month
|
|
Engagement
기간: 3-month
|
Engagement: We will be considered engagement a success if AYAs in NUDGE respond to an average of 4/7 (57%) messages each week during the first 3 months that a participant uses NUDGE. |
3-month
|
|
Acceptability
기간: 3-month
|
Acceptability: We will consider NUDGE acceptable if users report a satisfaction rating of ≥3 (mostly satisfied) on our modified Client Satisfaction Questionnaire and rate it as usable as ≥70% of other computerized systems on the System Usability Scale. We will also be attentive to themes in relation to the barriers and facilitators of using NUDGE and its success in promoting PA in interviews. |
3-month
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Actigraphy
기간: Baseline, 3-month, and 6-month
|
We will objectively measure AYA's moderate-to-vigorous PA for 7-days via ActiGraph wGT3X-BT accelerometers. All data will be processed using Actilife software. We will remove periods of non-wear and sleep; days with >10-hours of valid data during waking hours will be retained. Data will be binned into 15 second epochs and processed using the Chandler algorithm. |
Baseline, 3-month, and 6-month
|
|
Lung Functioning
기간: Baseline, 3-month, and 6-month
|
Lung function will be assessed for 7-days via the AM1+ portable spirometer. AYAs will undergo a standardize training and complete three maximal effort blows every morning and evening. The main outcomes will be forced expiratory volume in one second (FEV1) percent predicted. |
Baseline, 3-month, and 6-month
|
|
CF Quality of Life
기간: Baseline, 3-month, and 6-month
|
AYA CF-related quality of life will be assessed via the Cystic Fibrosis Questionnaire-Revised. |
Baseline, 3-month, and 6-month
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- 2158063
- 003780A122 (기타 보조금/기금 번호: Cystic Fibrosis Foundation)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
Plans to share IPD will need to be discussed with the IRB.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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